University:
University of Wolverhampton
Course:
4PY019 | Pharmacy
Academic year:

2024
Views:

103

Pages:

2
Author:

Sara

1. You are a pharmacist working on a hospital ward when a new patient comes in. The doctor asks you to take her drug history. She is on a number of different medications including a herbal product called St John's Wort and some homeopathic tablets called arnica a) - St John's wort is commonly used for depression but can interact with various medications - describe arnica as a homeopathic remedy often used for pain + inflammation, with a limited scientific evidence - assess the risk + benefit of 1) The patient says that she thought that St these products John's Wort + arnica would be ok to take - for arnica tablet = no evidence with her other tablets because they are of efficacy only 'natural'. She appears to know very little about these products/differences be- b) - natural does not always gutween them. rantee safe, as many medications are derived from natural a) What information about these products sources but can still have side would you tell him? effects + interactions b) How would you respond to his state- emphasise the importance ment that they are only 'natural'? of discussing all products with Explain your answer below (10 marks) healthcare providers to ensure safe + effective treatment 2. On closer inspection of the box of St John's Wort, you see that it is marked with a THR symbol. a) What does the 'THR' mark mean and when is this granted? b) Are you likely to see this on the arnica tablets? a) THR = Traditional Herbal Registration - it is granted to herbal products with at least 30 years of safe traditional use, meeting quality + safety standards b) Not see THR, as arnica is not associated with same level of traditional use that meets criteria for THR (arnica be granted by registration certificate) 3. You work in regulatory affairs for a drug company. Your company has discovered a new drug entity known as 'drug x' and put it through clinical trials successfully. You 1/2 Before selling the formulated drug as a medicine, regulatory steps are crucial: 1) obtain marketing approval have now formulated the drug as a 50 mg tablet + intend to sell it in the UK as a treatment for arachnophobia. Describe the steps that you would need to take before you can start selling the formulated drug as a medicine from the MHRA 2) comply with the Medicines Act regulations 3) demonstrate 'drug x' safety, quality + efficacy through studies 4) MHRA evaluates benefit-risk As part of your answer, you need to con- balance, manufacturing quality sider: + labeling before granting ap- what approval you need and from whom proval - the Regulations which govern it - what you need to demonstrate about 'drug x' - what will be considered before approval is given (12 marks) 4. Describe the steps that you would need to - Before a drug product can take before you can start selling the formu- be sold, it must go through a lated drug as a medicine: process of obtaining a manufacturing license to ensure that the manufacturing facilities meet the required standards for quality + safety - once the manufacturing license is in place, the next step would be to seek MA to sell the product legally in the market - both the manufacturing license + MA are essential regulatory steps in the process of bringing a new drug to market 2/2